Genfit has stopped development of VS-01 in acute-on-chronic liver failure (ACLF) after a patient suffered a serious adverse event in a phase 2 trial.
The French drugmaker acquired VS-01 when it bought Versantis for 40 million Swiss francs ($50 million) in 2022. Genfit subsequently made ACLF its top priority, advancing a phase 2 trial of VS-01 in the setting while expanding its pipeline to include six programs. After making changes to address slow enrollment, the biotech was aiming to publish phase 2 data on VS-01 in ACLF this year.
Genfit disclosed a change of plan after the U.S. stock market closed Friday. The company has stopped development of VS-01 in ACLF in response to a case of peritonitis, a condition characterized by inflammation of the tissue that lines the abdomen.
The independent data monitoring committee concluded the Unveil-IT study can continue, Genfit said, but it would require additional monitoring. Genfit opted against continuing the study with the suggested precautions after considering the target population’s clinical profile and the implications of the safety signal for the benefit-risk profile of VS-01 in ACLF.
Genfit is stopping the phase 2 Unveil-IT trial and a proof-of-concept study, both of which were focused on ACLF. The biotech is continuing its preclinical evaluations of the asset in urea cycle disorder (UCD). Genfit noted differences between UCD and ACLF patients and drug administration setup, plus evidence of the effect of VS-01 on ammonia clearance, to explain its decision.
The biotech will continue to develop four other assets in ACLF. Those candidates have different routes of administration and mechanisms of action than VS-01, suggesting they may be free from the safety signal, but are earlier in development. Genfit’s next data drop will cover safety results and early signs of efficacy from a study of G1090N in healthy volunteers. The biotech has scheduled the data release for late 2025.
Genfit predicted that axing the development of VS-01 in ACLF will substantially reduce its spending. The biotech said it could use cash freed up by the discontinuation to extend its runway by at least one year, pushing the end beyond 2028, or to strike deals. Guggenheim analysts said in a note to investors that the company may have the strategic flexibility to pursue opportunities for additional early-stage ACLF assets.